As part of the NRC's Human Health Therapeutics Research Centre, this new facility is designed to produce the material required to conduct early clinical trials on vaccines and other biologic medicines.
The clinical trial material facility will broaden Canada's domestic biomanufacturing capacity and enable Canadian-made biopharmaceuticals to advance to clinical trials in Canada.
About the facility
The clinical trial material facility is intended to accelerate the development of biopharmaceuticals like viral vector, protein subunit and virus-like particle vaccines, as well as other biologics.
With the capacity to replicate drug production processes that comply with good manufacturing practices (GMP) at a smaller scale, it will produce the quantity of materials required to conduct human clinical trials.
It can also be used as a technology transfer hub to complete verification runs and optimize GMP manufacturing processes, enabling testing, analysis and evaluation of the production process, including scaling up and scaling down.
As an essential part of increasing Canada's biomanufacturing capacity, the clinical trial material facility is a product development bridge between research and development, and the production of late‑stage or authorized vaccines and other biologic medicines.
About clinical trials
Clinical trials are research studies involving human participants that evaluate the safety and effects of a vaccine, drug or other intervention. Data from clinical trials can be used to support the approval of drugs for Canadians or to compare different medicines or treatments.
To ensure accuracy and safety, the material being used for clinical trials must be produced using the exact process intended for the final product. This includes following GMP, which ensure that drugs meet the quality standards appropriate to their intended use.
Visit Canadian Institutes of Health Research (CIHR) for more information about clinical trials in Canada.
Facility characteristics
- approximately 1,700 square metres (18,500 square feet)
- 5 litre and 500 litre bioreactors
- warehouse
Construction and qualification
Construction of the clinical trial material facility was completed in 2023. Teams from the Human Health Therapeutics Research Centre are now working on the complex commissioning, qualification and validation (CQV) process, which ensures the facility is GMP compliant and that materials produced in the facility will be safe for human use. It is expected to be completed in 2024.
At the same time, the teams are developing an extensive and comprehensive set of standard operating procedures (SOPs) to outline exactly how each piece of equipment, each room and every process will operate and be GMP compliant. This includes developing, reviewing and training on the application of SOPs for everything from how to write a standard operating procedure to how to operate a bioreactor.
Why work with us
Building on more than 30 years of experience in biomanufacturing research and development, the clinical trial material facility will enable the NRC to work with industry, academia and government collaborators on vaccines and other biologic medicines from innovation through the clinical trials stage of development.
The NRC's research labs at the Human Health Therapeutics Research Centre and the clinical trial material facility are designed to operate together or separately, depending on the requirements for a particular project.